ADD CONDITION

items per page

Vichy Laboratoires Normaderm Phytoaction Deep Cleansing

Last content change checked dailysee data sync status

Active ingredient
Salicylic Acid 5 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
December 11, 2023
Active ingredient
Salicylic Acid 5 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
December 11, 2023
Manufacturer
COSMETIQUE ACTIVE PRODUCTION
Registration number
M006
NDC root
69625-306

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is used for the treatment of acne, a common skin condition that can cause pimples, blackheads, and other blemishes. It works by targeting the factors that contribute to acne, helping to clear your skin and prevent future breakouts. If you're struggling with acne, this treatment may be a helpful option to consider in your skincare routine.

Uses

If you're dealing with acne, this medication is specifically designed to help treat this common skin condition. Acne can be frustrating, but with the right treatment, you can see improvements in your skin's appearance and health.

It's important to note that this medication does not have any teratogenic effects, meaning it does not cause birth defects. This makes it a safer option for those who may be concerned about such risks. Always consult with your healthcare provider to determine the best treatment plan for your individual needs.

Dosage and Administration

To use this product effectively, start by wetting your face with water. Then, take a small amount of the product and work it into a lather using your hands. Gently massage the lather onto your face, being careful to avoid your eyes. After you’ve applied it, rinse your face thoroughly with water.

For the best results, make sure to use this product twice a day. This routine will help keep your skin clean and refreshed.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

This product is intended for external use only, so please avoid using it internally. There are no specific adverse reactions or side effects reported, which suggests that it is generally well-tolerated. However, as with any product, it's important to monitor your body’s response and consult a healthcare professional if you have any concerns.

Warnings and Precautions

This product is intended for external use only, so please avoid ingesting it. If you accidentally swallow any of it, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific precautions or laboratory tests required for this product, but it's always a good idea to use it as directed. If you have any concerns or experience unusual reactions, don’t hesitate to reach out to your healthcare provider for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you're unsure.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits of using this medication while pregnant are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

Since there are no guidelines or precautions provided, it's a good idea to consult with your healthcare provider to discuss any concerns you may have about breastfeeding while using this medication. They can help you weigh the benefits and risks based on your individual situation.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to be cautious when using multiple acne treatments. If you use another topical acne medication alongside this one, you may experience increased skin irritation and dryness. To minimize these side effects, it's best to use only one topical acne medication at a time.

Always discuss your current medications and any new treatments with your healthcare provider. They can help you understand the best approach for your skin care routine and ensure that you avoid any unnecessary irritation.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, using it twice a day for best results. It's important to keep the medication out of reach of children. If the medication is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is this drug used for?

This drug is used for the treatment of acne.

How should I use this drug?

You should use it twice daily. Wet your face, work the product into a lather, massage it onto your face avoiding the eyes, and rinse well.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Keep it out of reach of children.

What should I do if I swallow this product?

If swallowed, get medical help or contact a Poison Control Center right away.

Can I use this product with other topical acne medications?

Using this product with another topical acne medication may increase the risk of skin irritation and dryness. It's best to use only one topical acne medication at a time.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

Is this drug safe to use during pregnancy or while nursing?

No specific information regarding safety during pregnancy or nursing is provided.

Packaging Info

Below are the non-prescription pack sizes of Vichy Laboratoires Normaderm Phytoaction Deep Cleansing (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vichy Laboratoires Normaderm Phytoaction Deep Cleansing.
Details

Drug Information (PDF)

This file contains official product information for Vichy Laboratoires Normaderm Phytoaction Deep Cleansing, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the treatment of acne. There are no teratogenic effects associated with its use, and no nonteratogenic effects have been reported.

Dosage and Administration

The product is to be used twice daily. Prior to application, the patient should wet their face thoroughly. A sufficient amount of the product should then be worked into a lather. The lather must be gently massaged onto the face, taking care to avoid contact with the eyes. After massaging, the product should be rinsed off well with water.

Contraindications

There are no specified contraindications for the use of this product. No conditions or situations have been identified that would warrant avoidance of use.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately to ensure appropriate care is provided.

No general precautions or laboratory tests have been specified for this product. Healthcare professionals should remain vigilant and monitor patients for any adverse reactions associated with external use.

Side Effects

For external use only. No specific adverse reactions or side effects have been reported in clinical trials or postmarketing experiences. Patients should be advised to use the product as directed and to consult a healthcare professional if any unexpected reactions occur.

Drug Interactions

Concurrent use of topical acne medications may increase the risk of skin irritation and dryness. It is advisable to limit the use of topical acne treatments to one at a time to minimize the potential for adverse effects. If irritation occurs, the patient should discontinue the use of additional topical acne medications and consult a healthcare professional for further guidance.

Packaging & NDC

Below are the non-prescription pack sizes of Vichy Laboratoires Normaderm Phytoaction Deep Cleansing (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vichy Laboratoires Normaderm Phytoaction Deep Cleansing.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the medication is swallowed. It is crucial for patients to understand the potential risks associated with accidental ingestion.

Additionally, healthcare providers should inform patients about the likelihood of skin irritation and dryness when using this medication concurrently with other topical acne treatments. Patients should be counseled to use only one topical acne medication at a time to minimize the risk of irritation. This guidance will help ensure safe and effective use of the medication while reducing the potential for adverse skin reactions.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically and is recommended for use twice daily. Clinicians should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients are instructed to seek medical assistance or contact a Poison Control Center immediately. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Vichy Laboratoires Normaderm Phytoaction Deep Cleansing, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Vichy Laboratoires Normaderm Phytoaction Deep Cleansing, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.